EN ISO 11138-2:2017
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

Standard No.

EN ISO 11138-2:2017

Release Date

2017

Published By

European Committee for Standardization (CEN)

Latest

EN ISO 11138-2:2017

Replace

FprEN ISO 11138-2:2016

EN ISO 11138-2:2017 Referenced Document

• ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
• ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
• ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
• ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment

EN ISO 11138-2:2017 history

• 2017 EN ISO 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
• 2009 EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
• 2006 EN ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes